Acute Effect of Pomegranate Extract on Cognitive Function

NCT02935777 | Completed Phase 1

• 1 other identifier: POM-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a two week intervention after a pre-intervention registration and preparation period. This study explores whether acute supplementation with pomegranate extract can modulate indicators of cognitive function and mood in healthy adults. Changes in physiological and biochemical markers are also investigated.

Conditions

Mental Processes

Keywords

Pomegranate extract; cognitive function; cognition; polyphenols; memory

Outcome Measures

Primary Outcomes (9)

• Simple reaction time (attention and vigilance, speed of attention)

  Reaction time in msec.

  1-2 hours

• Choice reaction time (attention and vigilance, speed and accuracy of attention)

  Arrows pointing left and right will appear on the screen at irregular intervals. The participant is required to indicate the direction of the arrow as quickly as possible, whenever an arrow is displayed. Measured by % accuracy, overall correct responses and reaction time (ms).

  1-2 hours

• Bond Lader mood scales

  Mood is measured via the Bond Lader series of mood scales, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alert', 'Calm' and 'Content', also presented as a score out of 100.

  1-2 hours

• Digit vigilance (attention and vigilance, speed and accuracy of attention)

  A fixed number will appear on the right of the screen and a series of changing numbers will appear on the left side of the screen. Participants are required to make a response when the number on the left matches the number on the right. Measured by reaction time (ms) and %accuracy of responses.

  1-2 hours

• Word presentation (secondary memory) then delayed Word recall (quality of memory)

  A list of words is displayed on the screen, one word at a time. Participants are given 60 seconds to write down as many of the words they were shown earlier as they can. This task was performed following following a delay between the presentation and recall (delayed recall). no of correct responses and % accuracy.

  1-2 hours

• Word recognition (secondary memory, quality and speed of memory)

  All target words that were shown during Word Presentation plus an equal number of decoys will be displayed on the screen one at a time. Participants indicate if they remember seeing the word earlier or not. measured by correct no of responses, errors and reaction time (ms).

  1-2 hours

• Rapid Visual Information Processing (RVIP) (cognitive demand)

  A series of numbers are displayed individually on the screen in quick succession (at a rate of 100 numbers per minute) and participants are required to respond when they see 3 odd numbers in a row or three even numbers in a row. Measured by % accuracy, no of false alarms and reaction time (ms).

  1-2 hours

• Picture presentation (secondary memory) and delayed recognition(secondary memory, speed and quality of memory)

  A series of pictures are displayed on the screen, one at a time. After a delay, all target pictures shown during Picture Presentation plus an equal number of decoys will be displayed on the screen one at a time. For each stimulus participants select 'Yes' or 'No' to indicate if they have seen the picture before or not. The task is measured by reaction time (ms), % accuracy and no of correct responses.

  1-2 hours

• Corsi blocks lite (working memory, spatial memory)

  Blue squares on a black background are displayed on the screen. Some of them change to red and back to blue again in a sequence. Participants are required to remember this sequence. The task is repeated five times at each level of difficulty with the sequence span increasing from 4 upwards, until the participant can no longer correctly recall the sequences. The task continues up to 6 squares in each sequence, while participants make enough correct responses. As soon as they make less than 3 correct responses (out of the five in one level) the task will end. All participants complete levels 4-6 regardless of incorrect responses. Results are measured by a span score: This score is calculated as the average of the last 3 correctly completed trials. For example, if the participant correctly responds to all five Level 4 trials and only one Level 5 trial, their span score would be 4.3 \[(4 + 4 + 5)/3\].

  1-2 hours

Secondary Outcomes (2)

• Pre and post blood pressure changes

  1-2 hours

• Pre-post cortisol and cortisone changes

  3-4 hours

Study Arms (2)

Pomegranate Extract

EXPERIMENTAL

POMANOX® pomegranate extract capsules with water by mouth, once. Dosage: 2 capsules Capsules weigh1.083g and contain: 210mg punicalagin, 328mg other pomegranate polyphenols (e.g. flavonoids and ellagic acid), 0.37mg anthocyanins and maltodextrin.

Dietary Supplement: Pomegranate Extract

Placebo

PLACEBO COMPARATOR

Identical placebo capsules by mouth, administered once. Dosage 2 capsules. Each capsule contains maltodextrin to provide PE capsule energy equivalent i.e.6.52 kcal or 27.28kJ.

Dietary Supplement: Placebo capsule

Interventions

Pomegranate Extract DIETARY_SUPPLEMENT

The first computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, intervention capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.

Also known as: POMANOX

Pomegranate Extract

Placebo capsule DIETARY_SUPPLEMENT

One computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, placebo capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Aged 18-65
• Enjoy computer tasks

You may not qualify if:

• Diagnosis with any neurological, psychiatric or significant medical condition which could affect cognitive function
• Known cognitive impairment
• Use of any prescription, herbal or recreational drugs
• Gastrointestinal disease
• Pregnancy or breastfeeding
• Pomegranate allergy

Sponsors & Collaborators

• Angela Stockton: lead
• Northumbria University: collaborator

Study Sites (1)

Queen Margaret University

Edinburgh, Scotland, EH21 6UU, United Kingdom

Location

MeSH Terms

Interventions

pomegranate fruit rind

Study Officials

• Emad Aldujaili

  Dean of Pharmacy, Jordan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Researcher

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 18, 2016
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)